We support you
No matter in which European or international market you want to market your medical device – an audit is the first step to check to what extent you comply with national standards or laws for medical devices.
EUROPe
This audit is carried out exclusively by a “Notified Body” such as TÜV Süd etc. and has various focuses on incorporating improvement potential into the existing processes. For example, the error and complaint management is considered.
The auditors check whether you have designed your QM documents in accordance with the standards and whether you live up to them. This means, for example, that you have already developed a product according to the standard and are now producing it.
You can prove this by providing your technical documentation (STED). In addition, the entire organization is taken into account, such as the range of further education and training measures or the handling of incoming orders right through to complaints.
If you successfully fulfill all necessary points, you will receive the DIN EN ISO 13485.
USA
TESTING ACCORDING TO 21 CFR PART 820
In the USA the FDA does not test according to DIN EN ISO 13485, but according to the legal regulation 21 CFR Part 820.
The FDA inspector then checks for any complaints or violations.
International
To harmonize the respective country-specific rules, laws and approval tests of DIN EN ISO 13485, Title 21 CFR Part 820 or ANVISA The Medical Device Single Audit Program (MDSAP) was introduced.
1.
First we clarify in a free preliminary talk what your requirements are.
You have developed a new product as an Original Equipment Manufacturer (OEM) and are now facing an audit? You are a contract manufacturer and are just setting up a QM system and want to implement a QM system?
We will clarify all necessary project steps with you in detail.
2.
We will then put together an individual team to support you directly on site.
We carry out an initial internal audit with you to analyze where your company stands and which requirements apply or have to be met.
On the basis of these results, we work with you to further develop existing processes so that economical, practice-oriented and standard-compliant procedures are created.
3.
We test whether we have achieved the goals set in the first internal audit with an initial analysis.
Here, however, we do not use the same team that developed these solutions, but an equally qualified and specialized team that can look at your processes objectively.
Only one thing remains the same: Your contact person will accompany you through all steps of our cooperation.
4.
This is followed by the post-processing of the audit, whereby you are then optimally prepared for the actual audit.
And also during the external audit, we are available to answer your questions and accompany you through the certification process.
5.
You pass the audit and can continue to sell your product on the market.
You will receive your desired certification.
